Impact of Microparticles on Postoperative Complications in Surgical Patients

Colorectal Neoplasms Clinical Trial

Official title:

The Impact of Microparticles on Inflammatory Responses During Visceral and Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677781
• Other study ID #: KEK251_07
• Status: Completed
• Phase: N/A
• First received: May 8, 2008
• Last updated: September 5, 2011
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: September 2011
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Microparticles are cellular fragments which are released actively or passively under conditions of inflammation and stress. The impact of surgical operations on quantity and quality of microparticles remains unknown. In this observatory study we investigate quantitative and qualitative aspects of microparticles during cardiac and abdominal operations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing cardiac or abdominal operations with a minimum expected operative time of 2 hours

Exclusion Criteria:

• Laparoscopic operations

• emergency operations

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm, Hepatic
• Neoplasms
• Pancreatic Neoplasms
• Postoperative Complications

Locations

Country	Name	City	State
Switzerland	Department of visceral and transplant surgery, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (16)

Andoh A, Tsujikawa T, Hata K, Araki Y, Kitoh K, Sasaki M, Yoshida T, Fujiyama Y. Elevated circulating platelet-derived microparticles in patients with active inflammatory bowel disease. Am J Gastroenterol. 2005 Sep;100(9):2042-8. — View Citation

Ardoin SP, Shanahan JC, Pisetsky DS. The role of microparticles in inflammation and thrombosis. Scand J Immunol. 2007 Aug-Sep;66(2-3):159-65. Review. — View Citation

Boulanger CM, Scoazec A, Ebrahimian T, Henry P, Mathieu E, Tedgui A, Mallat Z. Circulating microparticles from patients with myocardial infarction cause endothelial dysfunction. Circulation. 2001 Nov 27;104(22):2649-52. — View Citation

Chamouard P, Desprez D, Hugel B, Kunzelmann C, Gidon-Jeangirard C, Lessard M, Baumann R, Freyssinet JM, Grunebaum L. Circulating cell-derived microparticles in Crohn's disease. Dig Dis Sci. 2005 Mar;50(3):574-80. — View Citation

Diamant M, Tushuizen ME, Sturk A, Nieuwland R. Cellular microparticles: new players in the field of vascular disease? Eur J Clin Invest. 2004 Jun;34(6):392-401. Review. — View Citation

Fujimi S, Ogura H, Tanaka H, Koh T, Hosotsubo H, Nakamori Y, Kuwagata Y, Shimazu T, Sugimoto H. Activated polymorphonuclear leukocytes enhance production of leukocyte microparticles with increased adhesion molecules in patients with sepsis. J Trauma. 2002 Mar;52(3):443-8. — View Citation

Héloire F, Weill B, Weber S, Batteux F. Aggregates of endothelial microparticles and platelets circulate in peripheral blood. Variations during stable coronary disease and acute myocardial infarction. Thromb Res. 2003 Jun 1;110(4):173-80. — View Citation

Jimenez JJ, Jy W, Mauro LM, Horstman LL, Soderland C, Ahn YS. Endothelial microparticles released in thrombotic thrombocytopenic purpura express von Willebrand factor and markers of endothelial activation. Br J Haematol. 2003 Dec;123(5):896-902. — View Citation

Morel O, Hugel B, Jesel L, Lanza F, Douchet MP, Zupan M, Chauvin M, Cazenave JP, Freyssinet JM, Toti F. Sustained elevated amounts of circulating procoagulant membrane microparticles and soluble GPV after acute myocardial infarction in diabetes mellitus. Thromb Haemost. 2004 Feb;91(2):345-53. — View Citation

Morel O, Jesel L, Freyssinet JM, Toti F. Elevated levels of procoagulant microparticles in a patient with myocardial infarction, antiphospholipid antibodies and multifocal cardiac thrombosis. Thromb J. 2005 Oct 11;3:15. — View Citation

Nieuwland R, Berckmans RJ, McGregor S, Böing AN, Romijn FP, Westendorp RG, Hack CE, Sturk A. Cellular origin and procoagulant properties of microparticles in meningococcal sepsis. Blood. 2000 Feb 1;95(3):930-5. — View Citation

Ogura H, Kawasaki T, Tanaka H, Koh T, Tanaka R, Ozeki Y, Hosotsubo H, Kuwagata Y, Shimazu T, Sugimoto H. Activated platelets enhance microparticle formation and platelet-leukocyte interaction in severe trauma and sepsis. J Trauma. 2001 May;50(5):801-9. — View Citation

Piccin A, Murphy WG, Smith OP. Circulating microparticles: pathophysiology and clinical implications. Blood Rev. 2007 May;21(3):157-71. Epub 2006 Nov 22. Review. — View Citation

Proulle V, Hugel B, Guillet B, Grunebaum L, Lambert T, Freyssinet JM, Dreyfus M. Circulating microparticles are elevated in haemophiliacs and non-haemophilic individuals aged <18 years. Br J Haematol. 2005 Nov;131(4):487-9. — View Citation

Soriano AO, Jy W, Chirinos JA, Valdivia MA, Velasquez HS, Jimenez JJ, Horstman LL, Kett DH, Schein RM, Ahn YS. Levels of endothelial and platelet microparticles and their interactions with leukocytes negatively correlate with organ dysfunction and predict mortality in severe sepsis. Crit Care Med. 2005 Nov;33(11):2540-6. — View Citation

van der Zee PM, Biró E, Ko Y, de Winter RJ, Hack CE, Sturk A, Nieuwland R. P-selectin- and CD63-exposing platelet microparticles reflect platelet activation in peripheral arterial disease and myocardial infarction. Clin Chem. 2006 Apr;52(4):657-64. Epub 2006 Jan 26. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morbidity		30 days	No
Secondary	Hospital stay		30 days	No
Secondary	Mortality		30 days	No